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U.S. Department of Health and Human Services

About FDA

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Medical Devices

FDA Basics
Health professional using glucose meter to prick finger of young girl Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH). 

The owner of the device/product could have designed it but then had it manufactured by a contract manufacturer.

Do You Know…
What It Means When FDA "Clears" or "Approves" a Medical Device?

When FDA review is needed prior to marketing a medical device, FDA will either "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or More...

FDA Basics Videos

Alberto Gutierrez 137 x144

Watch a video about diagnostic tests and personalized medicine

Alberto Gutierrez, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health on new diagnostic tests and personalized medicine.  Watch FDA Basics Videos...
 
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